Institutional Review Board
(IRB)
Office of Regulatory & Research Compliance
MSC 309 - (Phone) 437-3850 (Fax) 437-3855
orrc@albany.edu
Version 11.01.13
RESEARCH AT OR WITH INTERNATIONAL SITES
(DO NOT LEAVE ANY QUESTIONS BLANK, INDICATE N/A WHEN NECESSARY)
The IRB must ensure that participants of all research conducted by UAlbany internationally are
afforded protections that are at least equivalent to those provided in its policies. These policies
do not affect any foreign laws or regulations which may otherwise be applicable and which
provide additional protections to human subjects of research.
If a proposed study qualifies for exemption, the regulations do not require review at the foreign
site where it will be conducted. However, the IRB must determine that the study would qualify for
exemption in the country in which it will take place. Note: Even in exempt research, informed
consent, parental permission or child assent may still be ethically appropriate, and/or required
under local law.
Please provide the following information:
1. Identify the country(ies) where the study will be conducted:
2. Indicate whether an IRB or equivalent body or committee will review this research in
each of the countries listed above: (Attach copies of all approvals.)
Yes
No
3. If no, an alternative method for local context review is a statement provided by an individual or
organization that is able to evaluate the proposed study with regard to the “local context.” The
individual or organization must be someone with sufficient knowledge of the local research
context to be able to evaluate the study with respect to the local customs, culture, mores, values,
laws, traditions of the foreign site. The person or organization identified cannot be affiliated with
the research project.
a. Name of individual/organization providing local context:
b. Provide individual’s/organization’s qualifications to provide the local context
evaluation:
Individual/Organization: Please provide local context evaluation below or in a separate
letter. Be sure that the statement addresses:




The recruitment process. Does it violate the social norms of recruitment in the country?
Does informed consent ask subjects to waive any of their rights?
That questions, methods, procedures are appropriate to the foreign site (e.g., while
innocuous in the U.S. a question could be deemed offensive elsewhere.)
Do the study procedures pose any potential legal or social harm to the subjects?
Local context evaluation:
Name
Signature
Date
Please note that it is the primary investigators’ responsibility to be knowledgeable of and adhere
to local laws, regulations, and guidelines.